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Completed

NCT Number: NCT01137006

An Open-Label, Dose-Escalation Study of IMC-20D7S In Participants With Malignant Melanoma

A dose-escalation study designed to determine the safety, maximum tolerated dose (MTD), anti-melanoma activity, antibody blood levels and progression-free survival (PFS) in participants with malignant melanoma receiving IMC-20D7S either every 2 weeks or every 3 weeks.

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Key information

Conditions

Malignant Melanoma Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ImClone Investigational Site, Boston, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participant has histologically or cytologically confirmed cutaneous, mucosal, or uveal malignant melanoma which has progressed after or during at least 1 treatment with standard cytotoxic treatment or/and immunotherapy [for example (e.g.), treatment with cytokines, monoclonal antibodies, and vaccines] and is not regarded to be a candidate for a potentially curative, higher priority treatment for melanoma
  • Participant is ≥18 years of age
  • Participant has either measurable disease as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or evaluable disease
  • At least 21 days must have elapsed from major surgery, prior chemotherapy, prior treatment with an investigational agent or device, or prior radiation therapy. Relative to participant's treatment with non-approved biological products (eg, monoclonal antibodies), a minimum of 2 half-lives must have passed for eligibility to be considered
  • Participant has resolution of all clinically significant toxic effects of prior cancer therapy to Grade ≤1 according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.02 (NCI-CTCAE v4.02)
  • Participant has adequate hematological function, hepatic function, and renal function

Exclusion criteria

  • Participant has undergone major surgery [e.g., laparotomy, thoracotomy, removal of organ(s)] within 21 days prior to study entry
  • Participant has elective or planned surgery to be conducted during the trial
  • Participant has documented and/or symptomatic brain or leptomeningeal metastases
  • Participant is receiving systemic steroids or other immunosuppressive medications. (Intermittent use of steroid-containing medications e.g., for asthma exacerbation or for skin lesions is permitted)
  • Participant has an uncontrolled undercurrent illness
  • Participant has a concurrent active malignancy other than adequately treated nonmelanomatous skin cancer or other noninvasive carcinoma or in situ neoplasm
  • Participant has a known allergy to any of the treatment components (monoclonal antibodies or other therapeutic proteins such as fresh frozen plasma, human serum albumin, cytokines, or interleukins). In the event that there is suspicion the participant may have allergies, the participant should be excluded
  • Participant is pregnant or lactating
  • Participant has known human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) infection

Treatment and study plan

IMC-20D7S (Cohort 1A)

Biological

5 mg/kg i.v. every 2 weeks.

Administered every other week on Days 1 and 15 of each treatment cycle.

If no dose-limiting toxicity (DLT) in first 3 participants or 1 DLT in 6 participants, then enrollment into Cohort 2A.

Other names: LY3012215

IMC-20D7S (Cohort 2A)

Biological

10 mg/kg i.v. every 2 weeks.

Administered every other week on Days 1 and 15 of each treatment cycle.

If no DLT in first 3 participants or 1 DLT in 6 participants in Cohort 2A, then enrollment into Cohort 3A.

Other names: LY3012215

IMC-20D7S (Cohort 3A)

Biological

20 mg/kg i.v. every 2 weeks.

Administered every other week on Days 1 and 15 of each treatment cycle.

If no DLT in first 3 participants or 1 DLT in 6 participants in Cohort 3A, then enrollment into Cohort 4A.

Other names: LY3012215

IMC-20D7S (Cohort 4A)

Biological

30 mg/kg i.v. every 2 weeks.

Administered every other week on Days 1 and 15 of each treatment cycle.

Other names: LY3012215

IMC-20D7S (Cohort 1B)

Biological

10 mg/kg i.v. every 3 weeks.

Administered every 3 weeks on Days 1 and 22 of each treatment cycle.

If no dose-limiting toxicity (DLT) in first 3 participants or 1 DLT in 6 participants in Cohort 1B, then enrollment into Cohort 2B.

Other names: LY3012215

IMC-20D7S (Cohort 2B)

Biological

20 mg/kg i.v. every 3 weeks.

Administered every 3 weeks on Days 1 and 22 of each treatment cycle.

If no DLT in first 3 participants or 1 DLT in 6 participants in Cohort 2B, then enrollment into Cohort 3B.

Other names: LY3012215

IMC-20D7S (Cohort 3B)

Biological

30 mg/kg i.v. every 3 weeks.

Administered every 3 weeks on Days 1 and 22 of each treatment cycle.

Other names: LY3012215

Primary outcomes

  1. Maximum Tolerated Dose (MTD) of IMC-20D7S

    Time frame: Baseline to toxicity [up to end of Cycle 1 (4 or 6-week cycles)]

    The MTD was defined as the dose preceding the dose level at which 2 participants experienced a dose-limiting toxicity (DLT) during treatment Cycle 1. A DLT was defined as any Grade 3 or above toxicity that emerged during study treatment and was clearly not attributable to malignant melanoma or co-medication and was possibly, probably, or definitely related to IMC-20D7S in the judgment of the investigator. No DLT was observed in the study; a provisional MTD was established.

  2. Number of Participants With Serious Adverse Events (SAEs), Other Non-Serious Adverse Events (AEs), or Death

    Time frame: Baseline through 30 days post last dose (up to 31 weeks)

    A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.

Secondary outcomes

  1. IMC-20D7S Pharmacokinetics (PK): Maximum Concentration (Cmax)

    Time frame: Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 hours (h) post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.

    A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted.

  2. IMC-20D7S PK: Minimal Concentration (Cmin)

    Time frame: Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.

    A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted.

  3. IMC-20D7S PK: Half-life (t½)

    Time frame: Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.

    A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted.

  4. IMC-20D7S PK: Clearance (Cl)

    Time frame: Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.

    A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted.

  5. IMC-20D7S PK: Area Under the Concentration Versus Time Curve (AUC)

    Time frame: Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.

    A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted.

  6. IMC-20D7S PK: Volume of Distribution (Vd) at Steady State

    Time frame: Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.

    A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted.

  7. Number of Participants Who Develop Antibodies Against IMC-20D7S (Immunogenicity)

    Time frame: Prior to the first and second infusion in each cycle up to Cycle 7 (4- and 6-week cycles)

    Planned analyses for immunogenicity were not completed. A decision was made not to develop a validated immunogenicity assay because of the exploratory nature of the study and the analyses.

  8. Progression-Free Survival (PFS)

    Time frame: First dose to disease progression or death (up to 27 weeks)

    PFS was determined for participants who went beyond their first disease assessment and completed at least 1 treatment beyond Week 1 of treatment Cycle 3.

  9. Recommend Doses for Phase 2/3 Studies Based on MTD

    Time frame: Baseline to toxicity [up to end of Cycle 1 (4-or 6-week cycles)]

    It was decided for administrative reasons to discontinue dosing at the provisional MTD rather than progress to Phase 1b.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

An Open-Label, Dose-Escalation Phase 1/1b Study of the Anti-gp75 Monoclonal Antibody IMC-20D7S In Patients With Malignant Melanoma Who Have Progressed After or During at Least One Treatment With Standard Cytotoxic Treatment or/and Immunotherapy Therapy or For Whom Standard Therapy is Not Indicated

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 4, 2010
Registry last updated
Jun 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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